Breakthrough status given to Renew Bioscience’s Alzheimer’s treatment
pharmafile | November 3, 2021 | News story | Research and Development |
Renew Bioscience announced it has received Breakthrough Device Designation status from the FDA for the Cerezen® Device, a novel treatment for Mild Cognitive Impairment due to Alzheimer’s Disease (MCI) and mild dementia of the Alzheimer’s type (mild AD).
The Cerezen Device uses External Counterpulsation (ECP) therapy, which enhances blood flow and overall vascular efficiency. A significant risk factor for cognitive impairment and dementia is poor vascular health, and cerebral blood flow and endothelial function are believed to play a significant role in this. The Cerezen Device is a drug-free and non-invasive technology designed to improve cerebral vascular health by enhancing circulation, simulating the physiological effects of vigorous exercise and stimulating endothelial cell function through a series of treatment sessions.
The Cerezen Device must be used under the oversight of a healthcare professional.
“We are extremely pleased with the progress related to the Cerezen Device, specifically receiving the Breakthrough designation from the FDA,” Tony Robinson, Renew Bioscience COO, said. “We truly believe that Cerezen represents a momentous potential advancement in the treatment of Alzheimer’s and dementia, and we look forward to sharing some of the data from our recently completed pivotal study at the Clinical Trials on Alzheimer’s Disease (CTAD) Conference next month in Boston.
Renew Bioscience is a commercial stage medical technology company, dedicated to the clinical advancement and distribution of technologies associated with improved clinical outcomes related to cardiovascular, neurological, and overall anatomical functionality and wellness. Renew Bioscience focus on the foundational principal of improving cardiovascular functionality and circulatory efficiency, in order to revolutionise the treatment of some of the most harmful diseases faced today.
Ana Ovey
